Import Alert 80-06

(Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public).

Import Alert # 80-06

Published Date: 02/19/2013

Type: DWPE

Import Alert Name:

"Detention Without Physical Examination of Fraudulent and Deceptive Medical Devices"

Reason for Alert:

Devices listed in the Attachment are misbranded due to false or misleading labeling claims

Guidance:

Districts may detain, without physical examination, all designated devices from importation into the United States.

The following devices are excluded from coverage under this Import Alert and any investigation of such devices should not be included.

a. Devices intended exclusively for use upon animals (non-human), check with the Center for Veterinary Medicine.

b. Prescription devices, which are being marketed as such.

Product Description:

Fraudulent and deceptive medical devices (See Attachment)

Charge:

"The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a device which is misbranded in that its labeling is false or misleading" [Misbranding, Section 502(a)]."

Desc:CDRH has indicated this firm/product combination meets the criteria for DWPE as per information found in Import Alert #89-08.
9/24/2008 Notes:The firm?s website contains statements which represent or suggest that the device is adequate and effective. The representations or suggestions are false or misleading or otherwise contrary to fact because the device is not adequate or effective for stated purposes.
NOTE

Desc:CDRH has indicated this firm/product combination also meets the criteria for DWPE as per information found in Import Alert #89-08.
12/17/2008 Notes:Product labeling for the Omnivir device contains statements which represent or suggest the device is adequate and effective to ?Fight HIV/AIDS and related opportunistic infections and protecting the immune system;? which representations or suggestions are false or misleading or otherwise contrary to fact because the device is not adequate or effective for such purposes.
NOTE